Trial Review

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A randomised controlled trial of chiropractic neck manipulation for improvement of neck pain, postural and dynamic balance, and cognition in the elderly: A feasibility study

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Scientific title

Efficacy of chiropractic neck manipulation compared to sham manipulation in decreasing scores on the Dizziness Handicap Inventory, Neck Disability Index and other measures of balance and cognition in the community dwelling elderly

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Secondary ID [1]2826250

None

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Universal Trial Number (UTN)

U1111-1144-0406

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Non-specific dizziness2893160

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Chronic neck pain2893170

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Geriatric falls 2893180

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Condition category

Condition code

Musculoskeletal28965428965400

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Other muscular and skeletal disorders

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Neurological28965528965500

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Other neurological disorders

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Physical Medicine / Rehabilitation28965628965600

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Other physical medicine / rehabilitation

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Chiropractic manipulation of the neck will be administered to the experimental group with or without massage. Chiropractic manipulation will consist of gentle application of manual high velocity low amplitude thrust procedures commonly practised by chiropractors. Treatment will be delivered twice a week over a period of 8 weeks. All treatment sessions will take 30 minutes each. The decision to include or exclude massage will depend on the clinical judgement of the treating investigator in determining whether hypertonicity exists in the muscles of the neck.

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Intervention code [1]2872910

Treatment: Other

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Comparator / control treatment

The control group will be administered a sham manipulation procedure known as the Outcomes of Usual Chiropractic, Harm & Efficacy (OUCH) protocol as previously published (1). Briefly, this will involve the application of the practitioners hands to the participants neck as well as detuned ultrasound and the "sham" thrust of an Activator TM instrument set at zero. These treatments will be given twice a week over a period of eight weeks. Each sham treatment session will take 30 minutes.

Neck pain and concommitant dizziness or unsteadiness of three months duration or longer, whether constant or intermittent.

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Minimum age

65Years

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Maximum age

85Years

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Gender

Both males and females

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Can healthy volunteers participate?

No

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Key exclusion criteria

Diagnosed vestibular pathology such as Meniere's disease or benign paroxysmal positional vertigo (BPPV); history or cerebrovascular accident or myocardial infarct; psychiatric disease; active inflammatory spondyloarthropathies; recent spinal trauma; osteomyelitis; spinal tumours; acute myelopathy; those who have had neck spinal manipulative therapy or neck massage in the last three months.

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Group allocations will be concealed from the investigators by placing them in opaque consecutively numbers sealed envelopes. As participants become eligible for the study, envelopes will be opened by a research assistant not involved in the conduct of baseline or outcome measurements.

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

The subjects will be randomly assigned at the baseline appointment by using a permuted block randomisation protocol to one of two groups (n=20). The randomization schedule will be done by the study statistician before recruitment using a computer generated random list of numbers.

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Masking / blinding

Blinded (masking used)

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Who is / are masked / blinded?

The people receiving the treatment/sThe people assessing the outcomesThe people analysing the results/data

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Intervention assignment

Parallel

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Other design features

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Phase

Not Applicable

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

Data analysis will be performed using SPSS software for Windows (version 20). Results are expressed as mean (95% confidence intervals) or median (range) where appropriate. Student's t-test and chi-squared analysis will be used to compare continuous and categorical variables, respectively. Factors effecting final DHI scores will be evaluated with ANCOVA. Participant's age and baseline values for the corresponding dependent varibles will serve as co-variates in these analyses. Since this is a feasibility study a sample size calculation is unnecessary. This study will act as a pilot for the larger RCT planned for a subsequent stage where 44 subjects will be needed per group for 90% power in detecting a 20% change in the primary outcome measure (DHI), also factoring in a 30% rate of drop-out.

RMIT University Research and Innovation, City CampusGPO Box 2476 Melbourne 3001 VIC Australia

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Ethics committee country [1]2893790

Australia

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Date submitted for ethics approval [1]2893790

04/05/2012

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Approval date [1]2893790

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Ethics approval number [1]2893790

HREC 29/13

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Summary

Brief summary

The primary focus of this study is dizziness in the community dwelling elderly. Neck pain and dysfunction can cause dizziness and may be an important under-investigated risk factor for falls in the elderly. Neck manipulation is known to be effective for neck pain. There is also preliminary evidence that physical treatments administered to the neck (including manipulation) may improve dizziness. This study will use clinical rigorous research methods to determine whether chiropractic manipulation can be used to successfully treat dizziness, thereby lowering the likelihood of falls in the elderly. Falls in the elderly are a significant public health problem in need of new and innovative management strategies.